Ortho Intranet Site     Residency Program       Make a Gift       QGenda 
 

       

 

Research Quality Program

Science Culture and Accountability Plan (SCAP)

Any questions regarding the SCAP can be directed to: Dr. Steve George at steven.george@duke.edu, Vice Chair of Clinical Research for the Department of Orthopaedic Surgery and Research Quality Officer (co-leader of our Research Quality Team) Dr. Tomasa Barrientos De Renshaw at tomasa.barrientosderenshaw@duke.edu, Senior Research Scientist and Lead Research Administrator (co-leader of our Research Quality Team)

I. Guiding Principles
The Department of Orthopaedic Surgery’s Scientific Culture and Accountability Plan promotes and supports the Responsible Conduct of Research (RCR). Our department’s Scientific Culture and Accountability Plan (SCAP) applies to all departmental personnel engaged in research and documents our department’s efforts to ensure appropriate training is received in areas of research integrity, data acquisition and management, authorship, research collaborations, financial responsibility and conflicts of interest. The SCAP outlines the required training and communication policies of the Department of Orthopaedic Surgery to uphold individual and departmental accountability in our research practices.

II. Structural Organization of the Entity
The Department of Orthopaedic Surgery consists of the following research groups:

 

  • Research Focused Faculty

    • Basic Science and Translational Sciences

    • Bioengineering

    • Clinical Research

    • Implementation Policy Research

  • Clinical Research Unit

  • Physical Therapy

Under the supervision of the principal investigators are postdoctoral associates, graduate students, medical students, undergraduate students, visiting scholars, research scientists, research associates, research analysts, and research technicians.
 

III. Promoting a Culture of Accountability

Culture
The Department of Orthopaedic Surgery’s Research mission is to lead and conduct research with Impact, Rigor and Efficiency ensuring the highest possible standards in research. This will provide a framework for making consistent decisions, at all levels, that will promote a culture of scientific integrity. By upholding and following the practices outlined in our SCAP, the department supports a research culture that allows for concerns about methodology and data integrity to be raised without hesitation and provides mechanisms by which these concerns can be addressed fairly and expeditiously.

NIH resources on rigor and reproducibility (useful for education/training and grant applications):

- https://grants.nih.gov/reproducibility/index.htm

A) Education of faculty, staff, and trainees

 

Researchers and Administrators

Complete training and successful examination in areas of research integrity, data acquisition and management, authorship, research collaborations, financial responsibility and conflicts of interest.

Responsible Conduct in Research (RCR) Training
All faculty, staff (including visiting scholars and administrators), trainees (residents, fellows, postdoctoral associates, graduate students) and other personnel on active IRB protocols who are participating in any type of research will be required to complete RCR training. Research faculty and staff will complete one 100 level online self-directed RCR program every three years and one collaborative in-person RCR Program 200 level every three years: https://dosi.duke.edu/RCR. Graduate students, postdoctoral researchers, and undergraduate students will complete the RCR training as required by their respective program leaders.

Postdoctoral researchers: https://postdoc.duke.edu/responsible-conduct-research-policy-postdoctoral-appointees
Graduate Students: https://gradschool.duke.edu/professional-development/programs/responsible-conduct-research/rcr-requirements
Undergraduate students: https://ors.duke.edu/grants-contracts-and-compliance-responsible-conduct-research-training-and-certification-rcr/rcr-0

Personnel involved in research administration will complete the Responsible Conduct of Research for Administrators as soon as Duke’s RCR-A program is available to implement.

Financial responsibility and conflicts of interest
All faculty, staff (including visiting scholars and administrators), trainees (residents, fellows, postdoctoral associates and graduate students) and other personnel on active IRB protocols who are participating in any type of research will be required to complete and maintain updated conflict of interest forms: https://dosi.duke.edu/conflict-interest

Data management plan

All faculty, students, postdoctoral fellows, visiting scholars and staff are responsible for the proper acquisition, documentation, and storage of data generated in the process of performing research. In addition to being essential to the generation of scientific knowledge, proper data management is a best practice that ensures reliability and reproducibility of findings generated from our Department. Specific approaches and processes for data management will vary within our Department because of the wide breadth of research programs. However, the ultimate goal for each of the research programs is the same – to generate high quality, reliable, and reproducible data that becomes the basis for published scientific articles. Therefore, the Department has a general expectation that all source data used as the basis for any publication and/or materials used for grant applications to be deposited in a secure, auditable, centralized location that is readily accessible to the principal investigator, other members of the research team, and administrative personnel (inside or outside Duke) responsible for research oversite. An example of a specific Data Management Plan for a basic science laboratory is provided in the Appendix. 

 

Department Leadership

  • Provide regular (at least quarterly) open forums for critical discussion of ongoing research to ensure the highest possible standards in research.

  • Encourage all investigators to present their research findings to other investigators outside their own research group

  • Ensure that investigators and personnel engaged in scientific research complete all required institutional training modules in responsible data management

  • Encourage investigators to attend research education series and foster mentorship relationships (internal and external of department) for faculty who would like to be involved in research

  • Ensure that all divisional investigators implement and maintain policies for responsible data management within their research groups.

  • Encourage publishable manuscripts have a “minimal data set” that includes all variables needed to replicate the work, and this information is stored in a central location. 

  • Effectively differentiate between quality improvement and research for projects within the Division. Provide leadership that creates and fosters a scientific culture of integrity and accountability

  • Assure appropriate training is completed by all involved in research, including mentorship of faculty

  • Review and disseminate best practices in research integrity

  • Annual review of divisions’ research portfolio and practices

  • Liaise with Schools, departments, institutes and centers to ensure alignment and integration with their programs of scientific accountability

  • Provide mechanisms by which concerns about conduct or data integrity can be discussed and addressed

Forums for Discussion of Standards of Research

The department actively fosters an environment in which everyone is free to express concern and criticism. The department offers a number of closed and open forums to encourage critical discussion ensuring the highest possible standards in research. All department research personnel will be made aware of the school of medicine’s integrity hotline: 1-800-826-8109. The list of specific forums that regularly involved research discussions within the Department of Orthopaedic Surgery are described in our Research Quality Management Plan.

 

C) Voicing Concerns

Compliance violations or concerns on the conduct of research or data integrity must be brought to the attention of Dr. Steven George Research Quality Officer, Dr. Tomasa Barrientos De Renshaw and/or the Research Quality Team, so that they can be properly addressed. The issues can be reported using any of the following means, report directly to a supervisor, manager, division chief, administration leadership, research quality team, department chair, research integrity office or dean. Anyone who would like to anonymously report any concerns related to human research, conflict of interest, research misconduct, research financial accounting, research safety or other compliance matters can contact the Integrity Line at 1-800-826-8109.

Appendix

 

Example of Data Management Plan for a basic science laboratory

 

Data acquisition and management

 

Responsibilities:

All students, postdoctoral fellows, visiting scholars and staff are responsible for the documentation of all data generated in the process of performing research in the lab. In addition to being essential to the generation of scientific knowledge, proper data management is a good laboratory practice that ensures reliability and reproducibility in all our work. Because the ultimate goal is for findings made in our laboratory to become the basis for published scientific articles, it is of utmost importance that all source data used as the basis for any publication and materials used for grant applications to be deposited in a centralized location readily accessible to the PI and to other members of the laboratory or research group.

 

Expectations:

Laboratory Notebook:  All students, postdoctoral fellows, visiting scholars and staff must keep a detailed laboratory notebook. 

• If a paper notebook is used, an electronic version of such day-to-day activities will be placed in the shared server under a folder assigned to each researcher.  The folder should be updated bi-weekly at the latest, but preferably in real time. 

• If an electronic notebook like LabArchives is used the PI should have access to the notebook. The PI will discuss with individual lab members the most appropriate format for data management given the type of research being performed. All primary data should be stored such that investigators and other key collaborators will have access, and so that their access is not reliant on any one person’s personal account access. Primary data and modified data should be stored in a read only directory with timestamps for modifications. Genomic, proteomic, and metabolomic data sets should be archived and submitted to a repository for each specific field (e.g. NCBI geo). In general, the electronic format of day-to-day activity should include:

  1. Title- this should be descriptive. If there are multiple concurrent projects, the project name should precede the title.

  2. Date- the starting date of the experiment should be clearly stated.  If a multi-day series of experiments is being performed, the range of dates (start to finish) covering all experiments should be entered.

  3. Objectives – all experiments should start with a rationale as to why the experiment is being performed, the specific research question being asked or the tool(s) being built, and the anticipated results.

  4. Experimental Plan- a detailed description of the experimental outline, controls to be used, analysis to be performed, etc.

  5. Results- a summary of results and discussion of the significance of the experimental results to the stated objectives.  This section should have clear links to where primary data is stored, including any spreadsheets, raw images, microscopy data, or any source data derived from instruments.  Images of blots, DNA gels and key micrographs should be embedded into the electronic documentation.

  6. Conclusions- an assessment of the next steps to be taken based on the results and the research objectives.

Group Meeting Presentations:  All students, postdoctoral fellows, visiting scholars and staff are expected to present their research objectives and findings to the rest of the research group. The objective of these presentations is to receive feedback on the broad hypothesis underlying the work and the specifics of the experimental design, findings and interpretation. An electronic version of this presentation will be placed on the server under a folder titled Lab Group meetings.

Publications: The most important output of any laboratory’s research enterprise is their published scientific findings. The quality, integrity and reproducibility of the data underlying any published material is of paramount importance. During the assembly of Figures and Tables for submission of manuscripts, a copy of all the source date should be made and deposited under the folder Lab Manuscripts in the group server. This folder should contain all the source data used to generate the figures, including copies of all relevant primary raw data, including evidence that the experiment has been repeated numerous times.  In cases where the experiment did not repeat, clear documentation should also be included as to why these results were excluded. In a separate accompanying text document, information should be provided describing the processing of raw data (normalizations performed, parameters for image quantification, etc.), any statistical analysis used and the rationale behind their use.

Any reagents generated in the course of published studies should be carefully catalogued and deposited in the lab’s main strain, plasmid and/or antibody repositories.  At the time of publication, all materials should be present and accounted for and a list of these materials – and their location within the lab- included as a text file in the corresponding folder under Lab Manuscripts. All co-authors in any manuscripts should acknowledge in writing that they have deposited all relevant materials. The primary author is responsible for making sure all materials have been deposited and are properly documented.